Current partner codePEPTIDESDE
NCT07226778·Phase 1·INTERVENTIONAL

Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations

Status

Completed

Phase

Phase 1

Enrollment

348

Locations

4

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.

Interventions

Treatment arms and agents.

DRUG

Maridebart Cafraglutide

Maridebart cafraglutide will be administered SC.

Timeline

From registration to results.

  1. First posted

    Nov 10, 2025

  2. Study start

    Oct 10, 2025

  3. Primary completion

    May 28, 2026

  4. Study completion

    May 28, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jun 17, 2026

Outcomes

What the study measures.

Primary outcomes

Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide

Time frame · Up to Day 120

Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide

Time frame · Up to Day 120

Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide

Time frame · Up to Day 120

Secondary outcomes

Number of Participants with Treatment-emergent Adverse Events

Time frame · Up to Day 120

Number of Participants with Serious Adverse Events

Time frame · Up to Day 120

Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

Time frame · Up to Day 120

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria 1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index between ≥25.0 and \<40.0 kg/m\^2. Exclusion Criteria 1. History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. 2. History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol). 3. History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity. 4. History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (\>2 x the upper limit of normal) at screening or a fasting serum triglyceride level of \>500 mg/dL at screening. 5. Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years. 6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. 7. History or current signs or symptoms of cardiovascular disease (aside from controlled hypertension and controlled dyslipidemia), including but not limited to myocardial infarction, congenital heart disease, valvular heart disease, coronary revascularization, or angina. 8. History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in. 9. History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or their ingredients. 10. Estimated glomerular filtration rate ≤60 mL/min/1.73 m\^2, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation at screening or check-in. 11. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in. 12. Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in. 13. Current or prior use of all herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, unless deemed acceptable by the investigator (or designee) and in consultation with the medical monitor, as appropriate. 14. Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives, whichever is longer, prior to check-in. 15. Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received the investigational product.

Study locations

4 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Anaheim Clinical Trials

Anaheim, California, United States

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, United States

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Maridebart cafraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.